Highlights

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Document that protects investigators and institutions from being forced to release information that would identify research participants. Certificates protect against legal demands for information such as court orders and subpoenas.

Advisory committee composed mostly of nonfederal experts. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by the parent agency and the Government Services Agency, to ensure balanced representation for geographical area, women, and diversity and to satisfy other legal requirements.

Human subjects term indicating research conducted on human subjects or material of human origin that can be personally identified. Policy covers three types of large- and small-scale exploratory and observational studies:

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See the NIH Definition of Clinical Trial for a detailed explanation with footnotes.

Behavioral human subjects research involving an intervention to modify behavior (e.g., diet) fits this definition of a clinical trial.

Human subjects research to evaluate a laboratory test may be considered a clinical trial if the test would be used to make a medical decision, or the test entails more than minimal risk for subjects.

Clinical trials usually go through four phases:

Phase I tests a new intervention in 20 to 80 people for an initial evaluation of safety, e.g., to determine a safe dosage range and identify side effects.

Phase II studies an intervention in a larger group of people, usually several hundred, to determine efficacy and further evaluate safety.

Phase III studies the efficacy of an intervention in large groups of several hundred to several thousand subjects by comparing it to other standard or experimental interventions, while monitoringadverse events and collecting information that will allow safe use.

NIH-defined phase III clinical trial is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.

Phase IV study is done after an intervention has been marketed to monitor its effectiveness in the general population and collect information about adverse effects associated with widespread use.

Ensures site compliance with the protocol approved by the institutional review board, other documents, regulatory requirements, International Conference on Harmonization and Good Clinical Practice guidelines, adequacy of staff and facilities, and other items.

Compilation of all regulations issued by the agencies of the federal government and presidential executive orders, which are published in the Federal Register.

The CFR is divided into 50 volumes known as titles. Each title is divided into chapters, subchapters, parts, subparts (in some parts), sections, and paragraphs. Titles are revised at least once a year and issued quarterly.

Agreement ensuring that government employees do not publicly disclose a company's proprietary information and that a company does not publicly disclose the government's scientific findings before publication or before the government secures patent rights.

Legislation in the form of a joint resolution enacted by Congress when a new fiscal year is about to begin or has begun, providing budget authority for federal agencies and programs to continue operating until regular appropriations are enacted. Also called continuing appropriations.

Award establishing a binding legal procurement relationship between NIAID and a recipient, obligating the latter to furnish a product or service defined in detail by NIAID and binding the Institute to pay for it. See contract award.

Type of contract that provides for payment of allowable incurred costs. These contracts estimate total costs and establish a ceiling a contractor may not exceed except at its own risk without approval of a contracting officer.